Kornimate/medical-research-clean huggingface dataset:
the shine-cto trial

Conditions: Coronary Artery Disease; Chronic Total Occlusion of Coronary Artery; Percutaneous Transluminal Coronary Angioplasty

Summary: design: single center, double-blind, sham-controlled trial that will randomize symptomatic patients with a coronary chronic total occlusion (cto) to cto percutaneous coronary intervention (pci) or a sham procedure. all patients will receive optimal medical therapy. treatment:cto pci, as per standard clinical practice. control: patients randomized to sham-procedure will undergo only bilateral arterial access, without angiography or pci being performed. secondary endpoints: (1) greater improvement in saq-7 summary scores during the entire duration of follow-up (6 months) using a repeated measures analysis (2) greater improvement in individual components of patients' health status (3) greater improvement in exercise capacity (4) similar incidence of major adverse cardiac events (mace), both peri-procedural and long-term


Eligibility criteria:
inclusion criteria: * age 18 years or greater * willing and able to give informed consent. the patients must be able to comply with study procedures and follow-up. * referred for clinically-indicated cto pci * optimal medical therapy (at least two anti-anginal medications at maximum tolerated doses, aspirin, and statin) exclusion criteria: * coexisting conditions that limit life expectancy to less than 6 months or that could affect a patient's compliance with the protocol * recent (\<7 days) acute myocardial infarction * patient has no symptoms related to the cto * known allergy to aspirin or clopidogrel * increased risk of bleeding (need for warfarin, oral xa inhibitor, or thrombin inhibitor administration, recent \[within 30 days\] major bleed, known bleeding diathesis or coagulation disorder) * positive pregnancy test or breast-feeding * chronic kidney disease, defined as serum creatinine \> 2.5 mg/dl * severe peripheral arterial disease limiting exercise capacity
planned semi-elective lung tx study

Conditions: To Compare Lung Transplant Outcomes Between Study Patients and Standard Patients Who Have Already Undergone Lung Transplantation by Conventional Procedures; Lung Transplant

Summary: when suitable donor lungs become available for a consented recipient, and the donor cross clamp time occurs between 6pm and 4am, the transplant procedure (anesthesia starting time) will be allowed to be moved to a 6am start or later with the lungs being preserved at 10c cold static preservation upon organ arrival to our hospital using a specific refrigerator. the maximum allowed time between donor cross clamp and recipient anesthesia initiation will be 12h.


Eligibility criteria:
inclusion criteria: * primary lung transplantation * informed consent provided donor inclusion: age\<70 exclusion criteria: * re-transplantation * multi-organ transplantation donor exclusion criteria: * age \>70y * concerns with organ preservation technique
an observational study to analyze the prescription pattern of sugammadex and its effectiveness and safety

Conditions: Postoperative Complications; Neuromuscular Blockade; Anesthesia

Summary: the purpose of this observational study is to evaluate patients who are planning to administer sugammadex after rocuronium or vecuronium is used. the main questions it aims to answer are: 1. prescription pattern of sugammadex 2. effectiveness and safety of sugammadex since this study is observational, only data generated under daily treatment are to be collected, and no additional tests or drug administration is conducted for the study. the patients are observed from baseline to 24 hours after the initial administration of sugammadex.


Eligibility criteria:
inclusion criteria: * male or female adults aged 19 or older * is to undergo elective surgery under general anesthesia * is planned to use rocuronium or vecuronium as an nmba * is planned for extubation before/after being moved to the recovery room * asa physical status i - iii * patients who have signed the informed consent after receiving information about the purpose and method of this study exclusion criteria: * has myasthenia gravis or eaton-lambert myasthenic syndrome * has hypersensitivity to ingredients of sugammadex, rocuronium, or vecuronium * has received an investigational product within 12 weeks from the study enrollment or has plans to participate in another clinical trial during the participation of this study. * other subjects who are considered inappropriate to participate in this study by the judgment of the investigator.

Keywords: sugammadex rocuronium vecuronium
acceptance and commitment therapy for patients undergoing coronary artery bypass graft surgery

Conditions: Coronary Artery Disease; Vascularization

Summary: heart disease is the leading cause of death globally, accounting for 16% of the world's total deaths. the number of cases is expected to increase as our population ages. heart disease also results in large economic burden. it costs the united states about $219 billion per year. some patients have symptoms that aren't helped by drugs or other medical treatments. these patients will need a surgery that is called cardiac artery bypass graft (cabg) surgery. cabg helps to improve chest pain which is one of the most common complaints of heart disease, and has life-prolonging potential. a limitation of cabg is that it results in increased inflammation. these patients also report high levels of anxiety and depression. depression and anxiety in the several days surrounding surgery are related to several important things. these include worse health outcomes, worse quality of life, increased risk of death, and increased health care cost. acceptance and commitment therapy (act) is a kind of therapy. act is adaptable, easy to access, and effective in brief formats. act has been gaining evidence for its use in many patient samples. few studies have used act with heart disease patients. no known studies currently exist that have used act within the few days surrounding cabg surgery. to address this need, the investigators will conduct a two-arm feasibility randomized control trial (rct). patients will be randomized to one of two groups. the first group will complete a brief, 2-session telehealth act intervention. the second group will be a control group. the control will consist of treatment as usual. the investigators will evaluate the feasibility of this brief act intervention delivered in the peri-operative period. the investigators will also examine preliminary efficacy of the act intervention. the investigators will examine anxiety, depression, psychological inflexibility, well-being, and cardiovascular health-related quality of life. the investigators will also examine the intervention's impact on inflammation by measuring two inflammatory markers. the results from this study will also lay the groundwork for larger or multiple site rct studies.


Eligibility criteria:
inclusion criteria: * admission to the heart and vascular center at university of iowa hospitals and clinics (uihc) for urgent or elective cabg * access to a personal phone or device with video or audio capabilities * ability to provide informed consent * english fluency. exclusion criteria: * life-threatening comorbid (noncardiac) medical condition(s) * active suicidal ideation or intent * psychotropic medication use lasting less than four weeks * inability to provide informed consent and comply with study procedures * those undergoing repeat revascularization

Keywords: act cabg
a study of alks 3831 in subjects with schizophrenia and alcohol use disorder

Conditions: Schizophrenia; Alcohol Use Disorder

Summary: this double-blind, randomized study will evaluate the efficacy, safety and tolerability of alks 3831 in subjects with schizophrenia and alcohol use disorder (aud).


Eligibility criteria:
inclusion criteria: * has a bmi between 18.0 and 40.0 kg/m2, inclusive * has a diagnosis of schizophrenia * has a diagnosis of alcohol use disorder (aud) * has experienced an acute exacerbation of schizophrenia within the past 6 months * additional criteria may apply exclusion criteria: * is pregnant or breastfeeding * had first lifetime psychotic episode less than 1 year before screening or has experienced only a single lifetime psychotic episode * has a known or suspected intolerance, allergy, or hypersensitivity to olanzapine * has current or pending legal charges with the potential for incarceration * has a positive drug screen for opiates * additional criteria may apply

Keywords: alkermes schizophrenia alcohol use disorder alks 3831
determination of fractional flow reserve by anatomic computed tomographic angiography

Conditions: Coronary Artery Disease

Summary: this is a prospective, multi-center trial conducted at up to 20 us, canadian, european and asian centers designed to determine the diagnostic performance of ct-flow (the investigational technology) by coronary computed tomographic angiography (ccta) for non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to direct measurement of fractional flow reserve (ffr) during cardiac catheterization as a reference standard.

285 patient, prospective, multi-center trial conducted at up to 20 us, canadian, european and asian centers designed to determine the diagnostic performance of ct-flow (the investigational technology) by coronary computed tomographic angiography (ccta) for non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to direct measurement of fractional flow reserve (ffr) during cardiac catheterization as a reference standard

Eligibility criteria:
inclusion criteria: * age \>18 years * patients providing written informed consent * scheduled to undergo clinically-indicated non-emergent invasive coronary angiography (ica) * has undergone \>64 multidetector row ccta within 60 days prior to ica * no cardiac interventional therapy between the ccta and ica exclusion criteria: * prior coronary artery bypass graft (cabg) surgery * prior percutaneous coronary intervention (pci) for which suspected coronary artery lesion(s) are within a stented coronary vessel * contraindication to adenosine, including 2nd or 3rd degree heart block; sick sinus syndrome; long qt syndrome; severe hypotension, severe asthma, , severe copd or bronchodilator-dependent copd * suspicion of acute coronary syndrome (acute myocardial infarction and unstable angina) * recent prior myocardial infarction within 40 days of ica * known complex congenital heart disease * prior pacemaker or internal defibrillator lead implantation * prosthetic heart valve * significant arrhythmia or tachycardia * impaired chronic renal function (serum creatinine \>1.5 mg/dl * patients with known anaphylactic allergy to iodinated contrast * pregnancy or unknown pregnancy status * body mass index \>35 * patient requires an emergent procedure * evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure \<90 mmhg, and severe congestive heart failure (nyha iii or iv) or acute pulmonary edema * any active, serious, life-threatening disease with a life expectancy of less than 2 months * inability to comply with study procedures

Keywords: ccta coronary artery disease cad
preliminary efficacy, safety and pharmacokinetics study of nepadutant in infant with feeding intolerance

Conditions: Colic

Summary: the present pilot study is aimed to obtain preliminary data on the effect of three ascending oral dose levels of nepadutant on the relief of symptoms associated with feeding intolerance. in addition, the assessment of drug exposure (pk assessment) will provide additional information on the dose-effect relationship, thus supporting the dose selection and dosing schedule in the future studies.

feeding intolerance is a transient neuro-developmental phenomenon affecting 25% to 40% of infant and toddler, with a peak at 6 weeks of age. feeding problems include mainly vomiting, slow feeding, refusal to eat and colic. current non pharmacological interventions (e.g. message, restriction in maternal diet in breast-feeding infants) and pharmacological treatments (simethicone, antimuscarinic drugs and antiacids) are largely unsatisfactory. nepadutant is postulated to have a therapeutic effect in infant colic since it reverts exaggerated intestinal motility and sensitivity induced by different stimuli through the activation of neurokinin-2 receptors, without interferring on the on physiological gastrointestinal transit. this phase iia study is designed to test in each participant infant two out of three oral doses of nepadutant in order to measure its blood levels, safety and efficacy with each dose level to be given for 7 concecutive days. the experimental clinical phase encompasses the following periods: * screening period (no study medication), lasting approximately 7 days prior to randomization * treatment period, lasting fourteen days (7 days fore each dose)with once daily administration * a safety follow-up visit, approximately four weeks after start of treatment.

Eligibility criteria:
inclusion criteria: * infants with a clinical diagnosis of feeding intolerance. * age ≤ 6 months at the enrolment. * normal growth. * infants who can refrain from use of erythromycin, metoclopramide, antihistaminic drug, proton pump inhibitors (ppis), antacids, antimuscarinic drugs, simethicone and dimethicone from 1 week prior randomization until end of study. exclusion criteria: * any clinically relevant event (excluding those relevant to the condition under study) which has occurred within one week prior to randomization. * any pharmacological treatment starting within one week prior to randomization. * infants for whom a change in the diet (i.e. weaning) has been performed within one week prior to randomization or is planned during the study period.

Keywords: feeding intolerance infant tachykinin antagonist infant colic nepadutant
studying blood samples in young patients with cytopenia after a donor stem cell transplant

Conditions: Leukemia; Myelodysplastic Syndromes

Summary: rationale: studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research study is looking at blood samples in young patients with cytopenia after undergoing a donor stem cell transplant.

objectives: primary * to study hematopoietic chimerism in whole blood and different cell populations (i.e., cd14, cd15, cd 56, cd3, and cd19) as well as in dendritic cells and regulatory t cells after allogeneic hematopoietic stem cell transplantation with reduced intensity conditioning in patients with refractory cytopenia. * to compare the results of chimerism obtained with standard short tandem nucleotide polymorphism pcr (sensitivity 1%) with those obtained with single nucleotide polymorphisms pcr (sensitivity 0.1- 0.01%). secondary * to evaluate the relationship between mixed chimerism and hematological engraftment, overall survival, and event-free survival. * to study the impact of mixed chimerism in plasmacytoid dendritic and regulatory t cells on the incidence of acute and chronic graft-versus-host-disease. outline: this is a multicenter study. peripheral blood is collected from patients and donors prior to hematopoietic stem cell transplantation (hsct). patients also undergo blood sample collection on days 30, 60, 100, and 180 after transplantation. peripheral blood cells are enriched and separated into lineage-specific subpopulations (i.e., cd3, cd14, cd15, cd19, and cd56) which are then divided equally for either dna isolation via pcr or for flow cytometry. dna concentrations in pre-hsct donor and patient samples and in post-hsct subpopulation samples are determined using quantitative real-time pcr. samples are also analyzed for quantification of chimerism and detection of genetic markers via short tandem repeats- and sequence nucleotide polymorphism-based chimerism analyses.

Eligibility criteria:
disease characteristics: * diagnosed with refractory cytopenia * hypocellular bone marrow and normal karyotype * underwent stem cell transplantation (sct) from an hla identical (8/8) sibling, an hla identical (10/10) relative, or an hla identical or single allelic disparate unrelated donor * received a preparative regimen including either thiotepa or fludarabine phosphate * concurrently enrolled on ewog-mds-2006 patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: refractory cytopenia with multilineage dysplasia childhood myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes
cuhk jockey club tech-based stroke rehabilitation programme - arr

Conditions: Stroke

Summary: the hong kong jockey club charities trust has supported cuhk to launch a three-year project 'cuhk jockey club hope4care programme' to implement four evidence-based advanced rehabilitation technologies in 40 local elderly day care centres and rehabilitation centres, to benefit the community. our research team had developed the "augmented reality (ar) rehabilitation training system" that can be used as tools for rehabilitation by individuals who have suffered from a stroke or elderly. the system facilitates an active rehabilitative exercise.


Eligibility criteria:
inclusion criteria * diagnosis of ischemic brain injury or intracerebral haemorrhage shown by magnetic resonance imaging or computed tomography after the onset of stroke; * motor impairment in upper-limb, lower-limb, and/or balance; * no or mild spasticity on the lower-limb or upper-limb (mas≤2); * have sufficient cognition to follow the instructions provided by the rehab system. exclusion criteria * any additional medical or psychological condition that would affect their ability to comply with the study protocol, e.g., a significant orthopaedic or chronic pain condition, major post-stroke depression, epilepsy, artificial cardiac pacemaker / joint; * severe shoulder or arm contracture/pain; * severe knee or hip contracture/pain * pregnant women
comparison between the old diagnostic tools for paediatric undernutrition and the has recommendations

Conditions: Undernutrition

Summary: undernutrition is a widely under-diagnosed public health problem, including in pediatrics department. undernutrition prevalence in pediatrics departments is about 15 to 20%. until now, there has been no national consensus on the criteria to be used to diagnose paediatric undernutrition. until now, assessment focused on a range of non-consensus arguments that allowed the health care team to make its diagnosis. so, in the absence of well-defined criteria, diagnosis was based in part on experience and assesment team. since november 2019, the french high authority of health (haute authorité de santé - has) has suggested recommendations to standardize pediatric undernutrition diagnosis. the investigators offer to evaluate undernutrition prevalence differences diagnosed according to new has criteria compared to the previous diagnostic methodology. the investigator's secondary aim is to identify profiles of children who do match between the two diagnostics methods.

the investigators will conduct a prospective cohort without change in care. following classic patient admission in involved departments, the investigating team moves to the department to collect data. the measurements and informations collected are no different from those taken in the context of normal care. all anthropometric measurements correspond to recommendations of good practice. anthropometric measurements will be carried out by the healthcare team. with collected data the investigators will evaluate undernutrition for each child, according to the 2 diagnostics methods. for any diagnosis of undernutrition, the department dietician will be alerted so that the patient can be taken care of so it is done normally. data collected are as follows: simple demographic characteristics: age, sex, departmentsand principal diagnosis anthropometry: weight, height, brachial perimeter, head circumference birth weight and date of term of pregnancy. clinical history: all pathologies or clinical events that may be related to a weight variation. assessment of ingesta. a non-opposition will be asked

Eligibility criteria:
inclusion criteria: * patient under 18 years old (has 2019) * patient admitted to short and long-stay pediatric services at montpellier university hospital, other than maternity, neonatal, palliative care or resuscitation and rehabilitation department. exclusion criteria: * parental or child opposition * legal guardian unable to express consent

Keywords: nutrition antromopemtric data pediatry
a dose-escalation study of luna18 in patients with locally advanced or metastatic solid tumors (with expansion).

Conditions: Locally Advanced or Metastatic Solid Tumors

Summary: this is a phase 1 dose-escalation and cohort expansion study that will evaluate the safety, pharmacokinetics (pk), pharmacodynamics (pd), and preliminary activity of luna18 when administered as a single agent or in combination with other anti-cancer drugs in patients with locally advanced or metastatic solid tumors.


Eligibility criteria:
inclusion criteria: * age \>= 18 years at time of signing informed consent form * ecog performance status of 0 or 1 * patients with a histologically or cytologically proven diagnosis of a locally advanced, recurrent, or metastatic incurable solid tumor for which standard therapy either does not exist or has proven ineffective or intolerable * patients with documented ras alterations positive solid tumors * patients with measurable disease per recist v1.1 exclusion criteria: * significant cardiovascular disease, such as new york heart association (nyha) cardiac disease (class ii or greater), unstable angina, or myocardial infarction within the previous 6 months or unstable arrhythmias within the previous 3 months * patients with primary central nervous system (cns) malignancy, untreated cns metastases requiring any anti-tumor treatment, or active cns metastases * patients with current severe, uncontrolled systemic disease (including, but not limited to, clinically significant cardiovascular disease, pulmonary disease, or renal disease, ongoing or active infection) * patients with a history or complication of interstitial lung disease (ild)